Freedom of Information request (FOI 22/899)
Published 17 January 2024
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FOI 22/899
13th September 2022
Dear
Thank you for your request under the Freedom of Information Act (FOIA).
Please note, as is mentioned in the https://www.gov.uk/government/news/first-bivalent-covid-19-booster-vaccine-approved-by-uk-medicines-regulator, “The decision to grant approval for this booster vaccine in the UK was endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence”.
The Summary of Product Characteristics (SmPC) summarises in sections 4.8 (safety) and 5.1 (primarily efficacy) the clinical data submitted in relation to the bivalent version of the Spikevax vaccine. Please visit the following link to access the SmPC Regulatory approval of Spikevax bivalent Original/Omicron booster vaccine - GOV.UK (www.gov.uk)
A Public Assessment Report for this vaccine is in drafting, and should be published in the near future*. Public Assessment Reports are documents that the MHRA produces for the public which are based on the MHRA assessment report of a product/s with any commercially or personally confidential information removed.
*Section 22 – Information intended for future publication: the information you have requested is due to be published shortly. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit in providing a complete summary of the assessment of this vaccine in the immediacy. However, rather than release the documentation prematurely, we consider that the public interest will be better served by issuing the report widely once it is has been made complete / fully prepared.
We anticipate the PAR will be published within 60 days of grant off the CMA.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
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If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
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SK9 5AF
Yours sincerely
MHRA Customer Experience Centre